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CARA In Pain, ALKS Enlightened, FDA Expands Approved Use Of AMGN's Vectibix

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Today's Daily Dose brings you news about Acorda's progress with its Parkinson's therapy Inbrija; Alkermes' encouraging results from its ENLIGHTEN-1 study; FDA approval for expanded use of Amgen's Vectibix in wild-type RAS metastatic colorectal cancer; Cara's disappointing results from its phase IIb trial of CR845 in patients with osteoarthritis of the knee or hip and Windtree's failed AEROSURF study.

Read on...

Acorda Therapeutics Inc. (ACOR) has submitted a New Drug Application to the FDA, seeking approval of INBRIJA as a treatment for symptoms of OFF periods in people with Parkinson's taking a carbidopa / levodopa regimen.

OFF periods refer to the re-emergence of Parkinson's symptoms.

The NDA was submitted under the 505(b)(2) regulatory pathway. Whether or not the NDA has been accepted for review by the FDA will be known by the end of September.

ACOR closed Thursday's trading at $19.55, down 1.01%.

Aduro Biotech Inc. (ADRO) has initiated a phase II clinical study of its lead listeria-based immunotherapy construct CRS-207 in combination with Merck & Co. Inc's (MRK) cancer drug Keytruda for the treatment of patients with gastroesophageal adenocarcinoma who have failed two prior chemotherapy treatments.

The trial is designed to enroll approximately 70 patients. The primary efficacy endpoint is objective response rate, defined as the proportion of patients with either complete or partial responses.

ADRO closed Thursday's trading at $11.45, up 2.69%.

Alkermes plc (ALKS) on Thursday reported positive preliminary topline results from the first of two key phase III studies of ALKS 3831 for the treatment of schizophrenia.

The study, dubbed ENLIGHTEN-1, evaluated the antipsychotic efficacy, safety and tolerability of ALKS 3831 compared to placebo over four weeks in 403 patients experiencing an acute exacerbation of schizophrenia.

The Company said that ENLIGHTEN-1 met the prespecified primary endpoint, with ALKS 3831 demonstrating statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared to placebo.

Data from the second phase III study of ALKS 3831 for the treatment of schizophrenia, dubbed ENLIGHTEN-2, is expected in 2018.

ALKS closed Thursday's trading at $58.68, up 1.77%.

Amgen Inc. (AMGN) has received FDA approval for expanded use of Vectibix in wild-type RAS metastatic colorectal cancer as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.

Vectibix was first approved in 2006 for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens.

The drug generated sales of $611 million for Amgen in 2016, up 11% over 2015.

AMGN closed Thursday's trading at $172.59, down 0.85%.

Astellas Pharma Inc. (ALPMY.OB) is seeking FDA approval for expanded use of Myrbetriq in combination with VESIcare for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.

In the United States, Myrbetriq and VESIcare are each approved as a monotherapy by the FDA for the treatment of overactive bladder with symptoms of urge urinary continence, urgency and urinary frequency.

ALPMY.OB closed Thursday's trading at $12.06, down 1.83%.

Shares of Cara Therapeutics Inc. (CARA) plunged more than 28% in extended trading on Thursday, following disappointing results from its phase IIb trial of CR845 in patients with osteoarthritis of the knee or hip.

The phase IIb trial tested three tablet strengths of CR845, 1.0 mg, 2.5 mg and 5.0 mg, dosed twice a day (BID) over an eight-week treatment period in 476 patients with osteoarthritis of the hip or knee experiencing moderate-to-severe pain.

According to the study results, patients maintained on the 1.0 mg and 2.5 mg tablet strengths did not exhibit significant reductions in mean joint pain scores compared to placebo. However, statistical significance was achieved for the 5.0 mg dose in patients with osteoarthritis of the hip, noted the Company.

CARA closed Thursday's trading at $25.51, down 5.34%. In after-hours, the stock fell another 28.11% to $18.34.

The FDA has accepted for review the Biologics License Application for CT-P10, a proposed Monoclonal Antibody biosimilar to Roche's Rituxan.

Rituxan is approved to treat patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. Rituxan raked in revenues of 7.30 billion francs for Roche in 2016, up 3% over the prior year.

Celltrion Inc., a global biopharmaceutical company, and Teva Pharmaceutical Industries Ltd. (TEVA) are collaborating on the development of CT-P10. The FDA is expected to announce its decision on CT-P10 during the first quarter of 2018.

TEVA closed Thursday's trading at $32.83, up 0.06%.

Windtree Therapeutics Inc.'s (WINT.OB) phase 2b clinical trial of aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants, 28 to 32 week gestational age, dubbed AEROSURF, has failed to meet the primary endpoint of a reduction in nCPAP (nasal continuous positive airway pressure) failure at 72 hours.

Commenting on the study results, Steve Simonson, Chief Medical Officer, said, "While the results did not meet the planned top-line analysis, we are very encouraged to see that, when dose is delivered as intended, the 50 minute dose exhibited a positive treatment effect with a safety profile comparable to that of nCPAP and consistent with the results we obtained in our previously completed phase 2a open-label clinical trial in similar gestational age infants."

The Company plans to work with regulators and develop a phase 3 regulatory and clinical plan using its next generation aerosol delivery system, which will be devoid of the device-related treatment interruptions experienced in the AEROSURF trial.

WINT.OB closed Thursday's trading at $0.85, down 0.01%.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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